Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)
STAT Rx USA LLC
FENTANYL
FENTANYL 2.5 mg in 72 h
TRANSDERMAL
PRESCRIPTION DRUG
Fentanyl transdermal system is indicated for management of persistent , moderate to severe chronic pain that: - requires continuous, around-the-clock opioid administration for an extended period of time, and requires continuous, around-the-clock opioid administration for an extended period of time, and - cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/h (see DOSAGE AND ADMINISTRATION ). Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg
Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl transdermal system is supplied in sealed transdermal systems which pose little risk of exposure to health care workers. If the gel from the drug reservoir accidentally contacts the skin, the area should be washed with copious amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may enhance the drug’s ability to penetrate the skin. Do not use a fentanyl transdermal system patch if the seal is broken or the patch is cut, damaged, or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal. KEEP FENTANYL TRANSDERMAL SYSTEM OUT OF THE REACH OF CHILDREN AND PETS. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Apply immediately after removal from individually sealed package. Do not use if the seal is broken. For transdermal use only. A SCHEDULE CII NARCOTIC. DEA ORDER FORM REQUIRED. Manufactured by: Watson Laboratories, Inc Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2008
Abbreviated New Drug Application
FENTANYL - FENTANYL PATCH, EXTENDED RELEASE STAT RX USA LLC ---------- FENTANYL TRANSDERMAL SYSTEM C-II REVISED: AUGUST 2008 RX ONLY FULL PRESCRIBING INFORMATION FOR USE IN OPIOID-TOLERANT PATIENTS ONLY FENTANYL TRANSDERMAL SYSTEM CONTAINS A HIGH CONCENTRATION OF A POTENT SCHEDULE II OPIOID AGONIST, FENTANYL. SCHEDULE II OPIOID SUBSTANCES WHICH INCLUDE FENTANYL, HYDROMORPHONE, METHADONE, MORPHINE, OXYCODONE, AND OXYMORPHONE HAVE THE HIGHEST POTENTIAL FOR ABUSE AND ASSOCIATED RISK OF FATAL OVERDOSE DUE TO RESPIRATORY DEPRESSION. FENTANYL CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION. THE HIGH CONTENT OF FENTANYL IN THE PATCHES (FENTANYL TRANSDERMAL SYSTEM) MAY BE A PARTICULAR TARGET FOR ABUSE AND DIVERSION. FENTANYL TRANSDERMAL SYSTEM IS INDICATED FOR MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE CHRONIC PAIN THAT: REQUIRES CONTINUOUS, AROUND-THE-CLOCK OPIOID ADMINISTRATION FOR AN EXTENDED PERIOD OF TIME, AND CANNOT BE MANAGED BY OTHER MEANS SUCH AS NON-STEROIDAL ANALGESICS, OPIOID COMBINATION PRODUCTS, OR IMMEDIATE-RELEASE OPIOIDS FENTANYL TRANSDERMAL SYSTEM SHOULD ONLY BE USED IN PATIENTS WHO ARE ALREADY RECEIVING OPIOID THERAPY, WHO HAVE DEMONSTRATED OPIOID TOLERANCE, AND WHO REQUIRE A TOTAL DAILY DOSE AT LEAST EQUIVALENT TO FENTANYL TRANSDERMAL SYSTEM 25 MCG/H. PATIENTS WHO ARE CONSIDERED OPIOID-TOLERANT ARE THOSE WHO HAVE BEEN TAKING, FOR A WEEK OR LONGER, AT LEAST 60 MG OF MORPHINE DAILY, OR AT LEAST 30 MG OF ORAL OXYCODONE DAILY, OR AT LEAST 8 MG OF ORAL HYDROMORPHONE DAILY OR AN EQUIANALGESIC DOSE OF ANOTHER OPIOID. BECAUSE SERIOUS OR LIFE-THREATENING HYPOVENTILATION COULD OCCUR, FENTANYL TRANSDERMAL SYSTEM IS CONTRAINDICATED: IN PATIENTS WHO ARE NOT OPIOID-TOLERANT IN THE MANAGEMENT OF ACUTE PAIN OR IN PATIENTS WHO REQUIRE OPIOID ANALGESIA FOR A SHORT PERIOD OF TIME IN THE MANAGEMENT OF POST-OPERATIVE PAIN, INCLUDING USE AFTER OUT-PATIENT OR DAY SURGERIES (E.G., TONSILLECTOMIES) IN THE MANAGEMENT OF MILD PAIN IN THE MANAGEMENT OF INTERMITTENT PAIN [E.G., USE ON AN AS NEEDED BASIS (PRN)] (SEE CONTRAIND Læs hele dokumentet